By Dr Martin Lally
Director, Capital Financial Consultants Ltd
The government has recently released a report from the Covid-19 Public Health Advisory Group chaired by Prof David Skegg (the “Group”), relating to future Covid-19 policy, and intended to answer various questions.
The first of these questions was: “Is an elimination strategy still viable as international travel resumes and/or are we going to need to accept a higher level of risk and more incidence of COVID in the community”? Viability is a very low bar for any strategy to cross. More important is whether continued use of the elimination strategy is optimal. The Group recognised this deficiency in the question and proceeded to answer both questions.
In para 16, the Group concluded that continued recourse to elimination as international travel resumes is “the best option at this stage”. In para 10, they defined elimination as “zero tolerance towards new cases”. In para 15 they recognised that occasional large outbreaks may still occur, and proposed eliminating them by physical distancing, mask wearing, testing, contact tracing, and “localised elevations of alert levels”. The latter words are a euphemism for lockdowns. In para 5, they acknowledged that “no-one knows what the outcome of this pandemic will be in say 3-5 years’ time”, and that more dangerous covid variants may emerge. Lockdowns may then be even more frequent and severe than they have been to date.
In describing elimination as the “best option at this stage”, the Group implies that there are at least two alternatives to it. However, the only specific alternative mentioned by them involves ongoing “pronounced physical distancing, wearing masks in most indoor places, and separating high risk individuals from family and friends during winter months” (para 19). This is an extreme alternative to an elimination strategy. Governments do not in general adopt either of these extreme approaches to other contagious diseases, such as the flu, but instead adopt other approaches that impose no requirements upon the entire population. Such an approach might be appropriate for covid, but the Group does not even contemplate that possibility, let alone analyse it. Acting as if there is only one (extreme) alternative to one’s preferred policy when this is not the case is not analysis but marketing.
In support of its conclusion that continued recourse to elimination is optimal, the Group presented three arguments (in paras 17-21):
- Doing so ensures that “our health system is not overwhelmed by large numbers of patients requiring care.”
- Doing so will obviate the need for “pronounced physical distancing, wearing masks in most indoor places, and separating high risk individuals from family and friends during winter months”.
- Doing so preserves the option to later switch to the alternative strategy.
No disadvantages of the elimination strategy were mentioned. This cannot be because the Group believes there are none because it acknowledges their existence in its para 21, where it refers to the possibility that “the costs of elimination outweighed the benefits”. The Group does not identify these costs, but they include the GDP losses from lockdowns, the behavioural problems emanating from the attendant unemployment, and disruption to the education of students, and the Group accepts that future lockdowns are possible under an elimination strategy. As with acting as if there is only one (extreme) alternative to elimination, listing its advantages but not its disadvantages is marketing rather than analysis.
The normal practice in assessing health interventions in this country and elsewhere is to estimate the Quality Adjusted Life Years (QALYs) saved by an intervention net of its costs, and to favour it only if this difference is positive. The Group carries out no such analysis. It cannot be unaware of this standard practice, because every member is an expert in health policy (most at Otago University), and the University runs a program (BODE3) to identify the health interventions that satisfy this QALY test: https://league-table.shinyapps.io/bode3/
Furthermore, in respect of point 1, there is a clear implication that our health system is not currently overwhelmed. The contrary is true, and manifested in long queues for many operations, with some patients dying from the ailment in question (or another one) before they reach the head of the queue. Moreover, even if our health system sans covid were able to accommodate all demands on it, the emotive verb “overwhelmed” would cover every excess demand scenario down to only a handful of covid patient not being catered for. An analysis should estimate the extent to which the system would be “overwhelmed”, and the deaths that would result from that. An emotive verb is not a substitute for analysis.
Point 1 also implies that the capacity of our health system is an immutable feature of nature. However, its capacity can be increased, and should have been in response to the pandemic because the benefits of capacity increases (in the form of lives saved and/or lockdowns avoided or mitigated) dwarf the costs up to some point. Lack of time is not a viable excuse. The Chinese built a hospital in a week, and even the UK managed in the course of a few weeks to convert several existing buildings into hospitals with the capacity for thousands of patients (“Nightingale” hospitals). Our response over the 18 months since the pandemic arrived has been virtually imperceptible.
Finally, in respect of point 3, the Group states in its para 21 that “if it became clear over the next few years that the costs of elimination outweighed the benefits, it would be a simple matter to follow the example of other countries.” However, the Group’s report consisted only of listing the advantages of elimination, ignoring the disadvantages, and then declaring elimination to be the winner. The Group then favours something being done in the future by somebody else (in the form of recognising the costs of elimination and comparing them to its benefits) that it entirely fails to perform itself.
NZ doctors speaking out with science: a brave new declaration by NZ doctors and concerned citizens.
Simon Thornley, Gerhard Sundborn.
12 April 2021
We are usually supporters of vaccines, and our children are all immunised.
Yet we have deep unease that the least tested vaccine in living memory, for a virus posing little risk to most people, has been purchased at great cost, and is being commended to New Zealanders as “safe and effective”.
When Covid Plan B opposed the elimination strategy a year ago, it was not because of doubts over vaccines. We said the strategy was too costly to pursue while waiting for a vaccine. We said that most solutions were likely to be unwarranted by the small danger posed by SARS-CoV-2.
The early development of vaccine-like products is a triumph of science.
Plan B had worried that vaccines would take years to pass the usual safety and effectiveness tests. We hadn’t counted on the panic being so strong that usual stages would be curtailed.
The speed, haste, and enthusiasm with which covid-19 vaccines have been thrust upon us has made us pause and examine the evidence.
New Zealand has purchased enough of the Pfizer mRNA vaccine for everyone in the country. Several other supply arrangements exist in case one falls through.
We do not know the cost of the vaccines, as it has been hidden from us. Sources overseas indicate the cost to governments of the Pfizer/BioNTech vaccine as US$19.50/dose – or NZ$27.63 at current exchange rates. So for 10 million doses, NZ may have paid NZ$276 million.
That doesn’t include the costs of distribution, cold-chain, quality control and administration of the jab.
Is this vaccine worth the cost? What is the evidence for the vaccine’s benefit and are there any potential downsides?
A primary factor in whether a vaccine is warranted for a particular disease in pre-covid times has rested on three principal factors. These are, among others:
- Benefits for high-risk individuals compared to the whole population.
- Healthcare system and societal costs incurred by vaccination programmes compared to treating disease.
- Life years and quality adjusted life years gained because of vaccines.
The World Health Organization has released criteria which focus on clinical consequences, such as safety and efficacy, but also encompass other areas such as public health benefits such as the reduction of infection rate.
The document mentions the ‘preferred’ need for at least 70% vaccine efficacy, with consistent results in the elderly. 50% efficacy is considered minimal. The endpoint may be a combination of disease, severe disease, and or shedding or transmission. The document says 6 months of protection may be acceptable, but one year is preferable.
The WHO discussion of vaccine safety is vague. It says a ‘highly favourable benefit to risk profile’ is ideal, but the benefits outweighing the safety risks is ‘acceptable’.
A footnote mentions that the ‘potential for enhanced disease’ should be considered. Clearly, authors of the document are cognisant of the potential for antibody dependent enhancement, a phenomenon present for other viruses such as dengue, Zika, Ebola and other coronaviruses. This occurs when high antibody concentrations are initially effective against a pathogen, but waning immunity and lower concentrations paradoxically enhance the severity of infection.
The true cost of the epidemic is hard to pin down, and we’re yet to see a formal cost-benefit analysis of the effects of the vaccine, since the long-term effects of the product are unknown.
The main choice facing New Zealanders now is whether to be vaccinated with the Pfizer one, so we’ll focus on this. The main evidence relating to this vaccine is outlined in the New England Journal of Medicine. The trial randomly allocated ~40,000 participants, roughly half each into vaccinated and placebo groups and followed them for two months to see whether they developed covid-19 infection. The study excluded people under the age of 16, pregnant women and people with a history of either covid-19 or any immunocompromising condition. The primary outcome was defined by a positive PCR test, with at least one symptom of infection.
The headline results were 169/20,172 covid-19 events in the placebo group, compared to just 9/19,965 in the vaccine group, giving an efficacy of 94.6% after two months. The most reported side effects from the vaccine were transient, such as fatigue, headache, and muscle pain. The two-month trial did not address viral transmission nor long-term safety and effect.
The trial has come under scrutiny for unexplained incongruities. Further documentation has revealed that the rate of ‘suspected, but not confirmed’ covid-19 were similar between the two groups: with 1,594 cases in the vaccinated and 1,816 in the placebo.
There was also an imbalance in exclusions due to unexplained ‘protocol deviations’. In the vaccinated group 311 were excluded, compared to only 60 in the placebo. The chances of being excluded from the trial were therefore (311/21,720)/ (60/21,728) = 5.2 times higher in the vaccinated group, a ratio which is extremely unlikely to be due to chance (P < 0.001). This finding is buried in papers only made available to US regulators, rather than highlighted in the trial results. The selective exclusion of individuals in trials is an area commonly exploited by drug manufacturers to exaggerate claims. The best evidence conventionally comes from including all randomised subjects (‘intention-to-treat’), whether they deviate from the trial protocol or not. Requests for scrutiny of the trial data, to understand what factors lead to these exclusions, have been ignored.
Since the primary outcome of the trial is related to mild covid-19 events, we know little about whether the vaccine prevents deaths from the virus. Others have indicated that trials will not be sufficiently powered to detect differences in need for hospital treatment, let alone death from covid-19, since the number of subjects and resources required for such a trial would be prohibitive. We cannot assume that prevention of infection translates to fewer deaths. For influenza vaccinations, for example, even though they reduce infection, that has not translated into lower mortality after widespread uptake.
The vaccine has been studied in a healthy population who are largely unaffected by covid-19 hospitalisation or death, even with subjects drawn from supposedly ‘hard-hit’ regions, including the US, Brazil, South Africa, Germany, and Turkey. This trial evidence supports reductions in mild covid-19 infections only. We simply don’t know whether the vaccine will prevent what really matters: hospital and intensive care admissions and deaths.
The trial confirms that for people of working age, the risk of fatality from covid-19 is extremely low. So low in fact, that there will be too few deaths to run a trial without spending an extraordinary amount of money on a very large one. The conclusion by health authorities not to run a trial on vaccine effectiveness to prevent death means they themselves conclude that the fatality risk of the virus, and hence need for a vaccine, is overblown.
New Zealanders are being offered a covid-19 shot with the inaccurate assurance that it is “safe and effective”. From the evidence reviewed here, this message is disingenuous.
The long-term benefits and harms from covid-19 vaccines are unknown since they have only been recently used in humans. This is acknowledged in Medsafe’s 58 conditions for the emergency use. They require early alerts to company reports about the product’s safety and possible benefits. If the government’s own officials are sceptical and demand transparency, we should as well.
We should be concerned
6 April 2021
Like many gravitating to the Covid Plan B webpage, I am increasingly concerned about our government’s and indeed the global approach to the management of the Covid-19 pandemic. There are so many aspects of the present situation that seem so completely surreal.
From the philosophical perspective, I am deeply concerned about the adulteration of the scientific method. Am tired of hearing the media admonish us to trust the science and trust the experts. I constantly need to remind those around me that science is a tool, a method which if correctly applied will answer questions in a meaningful way bringing us progressively closer to an approximation of truth. It is primarily a process of observation and to make our observations meaningful these must be conducted in a carefully controlled manner.
By contrast, the force dominating our present world view is a deceitful yet carefully contrived facsimile of science. It uses all the vestiges, regalia and language of science without meeting the fundamental criteria. The policies and interventions which are being foisted upon us in the name of this pandemic are based not upon controlled observation, but rather upon narratives, rhetoric and data derived from some rather dubious uses of modelling. To make the distinction I will refer to this alternative paradigm of polemics and extrapolation as scientism. It is a sleight of hand, a wolf in sheep’s clothing, the proverbial cuckoo in the nest of the scientific method.
Examples of scientific fraud that have been perpetuated on our populous over the course of the present pandemic are sadly numerous. But I wish to focus here on the novel reversible gene therapy which is being deployed to our New Zealand population under the auspices of the disarming banner of the term “vaccine”. Vaccines are central to our medical approach to the prevention of severe human disease. However, the present technology has never been used for this application on prior occasions. It is disingenuous to include this technology within the trusted envelope of the term “vaccine” without evidence that it is both safe and effective for use in this capacity. The suggestion that an individual’s access to employment, ability to access services and ability to travel could depend upon their participation in this uncontrolled human experiment should be deeply alarming to anyone who places any value on human rights.
I have deep concerns about the speed at which these experimental “vaccines” are being presented as the only solution to the pandemic. No one has been able to answer the question as to how we can be confident that the recurring problem of antibody dependent enhancement which plagued our prior attempts to produce vaccines to other coronavirus variants in animal studies has been overcome. The main safety concern may not lie in the deployment of these “vaccines” but rather in the exuberance of the inflammatory response which follows the subsequent exposure of a patient to covid-19 or a future coronavirus variant.
Science aside, I am alarmed at the campaign of propaganda directed at the public through our mainstream media. The media’s phrasing of Covid-19 is hyperbole at best or worse – blatant fear mongering. By prefixing reports with phrase selection “the deadly virus” it is little wonder that many of our fellow New Zealanders are living in the state of fear that paralyses rational decision making. I am unaccustomed to living in an environment in which rational discussion has become verboten. Never have I seen anybody who dares to ask legitimate questions, shutdown so vehemently and labelled “controversial” or a “conspiracy theorist”.
It seems quite clear that we are only “allowed” to conform to the narrative being presented to us by our government and our trusted mainstream media. We once lived in a free society, with free speech and open dialogue, this no longer seems to be the case. Should we be concerned? I am.
The author: I do not wish to disclose my identity, at least for the time-being. I have undertaken a protracted tertiary education which includes degrees in science (cellular and molecular biology and biochemistry) medicine and dentistry and a doctoral degree with research in molecular biology. I am lucky to be a member of the fortunate educated.
In a speech to her Party Conference today, Prime Minister Jacinda Ardern has effectively ended the nation’s elimination strategy.
Early into the pandemic the Government shifted from policies that might ‘flatten the curve’ of the virus impact, to ones such as “lockdown” which might eliminate the virus in New Zealand. Jacinda Ardern said the strategy was to eliminate the virus. Media named the architect of the strategy as Michael Baker of Otago University. His plan was supported by other academics such as Rod Jackson and Siouxsie Wiles.
Covid Plan B said elimination of the virus from the country was not possible in the long term, and the cost of attempting it – on health, society and economy – was too high. In any case, elimination was not warranted because population health impacts of the virus were comparatively small.
Ardern’s words today acknowledge that Sars-CoV-2 will not be eliminated. Her description of the new goal is similar to those of us who have advocated learning to ‘live with the virus’. The Government’s answer now is a seasonal vaccination programme.
Ardern said that 2021 would be “the year of the vaccine… for the world”. “Our goal has to be though, to get the management of covid-19 to a similar place as we do seasonally with the flu. It won’t be a disease that we will see simply disappear after one round of vaccine across our population. Our goal has to be to put it in a place where as we do every year with a flu vaccination programme that we roll out a vaccine programme and maintain a level of normality in between time.”
A banal report from the Children’s Commissioner about life in lockdown for NZ kids has a few interesting findings when you dig into it.
By and large, it appears that our kids dealt reasonably resiliently with what the report stupidly claims to be “unprecedented times”
From their survey, half of kids’ parents worked at home and half went out to work – that’s a lot different from the “work from home” message that dominated the perspective of the Government.
Only 8% of kids list the public health messages as a memorable feature of the period.
The absolutely dominant feature and commonality among all kids is that they really missed and disliked the physical separation from their friends, particularly via school. That speaks to a reality of the lives of almost all of us – and something denied by lockdown and social distancing: we simply cannot live for very long separated from each other.